Biomechanical Treatment of CTS Via Carpal Arch Space Augmentation: A Pilot Clinical Trial

通过腕弓间隙增大治疗 CTS 的生物力学治疗：初步临床试验

• 批准号: 10725257
• 负责人: C KENT KWOH
• 金额: $ 54.03万
• 依托单位: UNIVERSITY OF ARIZONA
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2026-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10725257
• 关键词: Affect; Anatomy; Area; Basic Science; Biomechanics; Cadaver; Carpal Tunnel Syndrome; Clinic; Clinical; Clinical Research; Clinical Trials; Data; Devices; Diagnosis; Disease; Double-Blind Method; Dropout; Feasibility Studies; Finite Element Analysis; Future; Goals; Hand; Hand functions; Health Care Costs; Healthcare Systems; Height; High Prevalence; Human; Human Experimentation; In Vitro; Intervention; Intervention Studies; Investigation; Laboratory Study; Ligaments; Methods; Modality; Modeling; Multi-Institutional Clinical Trial; Nerve compression syndrome; Neural Conduction; Neuropathy; Numbness; Operative Surgical Procedures; Outcome; Pain; Patient Dropouts; Patient Outcomes Assessments; Patients; Physiological; Pilot Projects; Population; Preparation; Public Health; Quality of life; Randomized; Randomized Controlled Clinical Trials; Recovery; Recurrence; Reporting; Research; Research Project Grants; Sample Size; Site; Surgical complication; Symptoms; Techniques; Therapeutic; Therapeutic Effect; Translating; Translations; Treatment Efficacy; Treatment outcome; Width; Wrist; arm; clinical translation; compliance behavior; design; evidence base; experimental study; follow-up; hand rehabilitation; improved; in vivo; innovation; median nerve; nerve decompression; novel; pain symptom; pathomechanics; patient expectation; pilot trial; pre-clinical; pressure; recruit; reduce symptoms; retention rate; symptom management; symptomatic improvement; therapy design; treatment effect; trial comparing

ABSTRACT Carpal tunnel syndrome is a commonly diagnosed hand disorder that is routinely treated by surgically transecting the transverse carpal ligament to reduce pressure on the median nerve and to alleviate symptoms. Despite known complications of surgery, including reduced hand function and symptom recurrence, the surgical technique has remained fundamentally unchanged since the early twentieth century. Non-surgical interventions where the wrist is therapeutically manipulated have been developed, but these modalities have not gained widespread acceptance due to a lack of scientific and clinical evidence of efficacy. Our previous investigations have identified a novel mechanism for median nerve decompression, the core concept of which is that radioulnar wrist compression leads to carpal arch space augmentation (CASA) and, subsequently, to median nerve decompression. In contrast to currently available therapeutic methods which aim to increase the width of the carpal arch, our approach narrows the arch width in order to increase the arch height and cross- sectional area. This novel biomechanical intervention is supported by our extensive research including in vitro cadaveric experiments, geometric modeling, finite element analysis, in vivo human experimentation, and preclinical feasibility studies. Building upon these scientific and clinical premises, we plan to carry out a single site, double-blinded, randomized controlled clinical trial pilot study to demonstrate the treatment efficacy of CASA for carpal tunnel syndrome and compare the therapeutic effects with a sham device. The Specific Aims of the project are (1) to demonstrate that non-surgical CASA intervention improves symptoms and hand function in patients with carpal tunnel syndrome; (2) to compare the clinical outcomes of CASA intervention with a sham intervention; and (3) to demonstrate the feasibility and scalability of a multisite, randomized controlled, full-scale clinical trial comparing CASA intervention and sham intervention. We hypothesize that (i) four-weeks of CASA intervention will alleviate carpal tunnel syndrome symptoms and improve hand function and that the beneficial effects will persist beyond the intervention period; (ii) CASA intervention will result in greater improvement of symptoms and function than the sham intervention; and (iii) recruitment will be feasible, retention rates and compliance will be acceptable, and the treatment will be safe. Results of this pilot clinical trial will allow us to understand the expected treatment effects of CASA intervention, refine sample size, set expectations for patient compliance and dropout rates, and inform the design of a larger scale multisite randomized controlled clinical trial of CASA intervention. This pilot trial is a crucial step in our preparation to effectively launch a full-scale multisite clinical trial, eventually translating our scientifically meritorious biomechanical principle of CASA and research findings into a novel non-surgical treatment of carpal tunnel syndrome.

抽象的 腕管综合症是一种通常被诊断出的手术治疗 横断横向腕韧带，以降低中正神经的压力并减轻症状。 尽管已知的手术并发症，包括手部功能和症状复发，但 自20世纪初以来，手术技术一直保持不变。非手术 已经开发了手腕治疗的干预措施，但这些方式具有 由于缺乏科学和临床疗效证据，因此无法获得广泛的接受。我们的先前 调查已经确定了一种新颖的神经减压机制，这是核心概念 是Radioulnar手腕压缩导致腕拱空间增强（CASA），然后 中位神经减压。与当前可用的治疗方法相反，旨在增加 腕弓的宽度，我们的方法缩小了拱形宽度，以增加拱形的高度和跨 区域区域。我们的广泛研究（包括体外）支持了这种新颖的生物力学干预措施 尸体实验，几何建模，有限元分析，体内实验和 临床前可行性研究。在这些科学和临床前提下，我们计划进行一次 站点，双盲，随机对照临床试验试验研究，以证明治疗疗效 CASA用于腕管综合征，并将治疗作用与假装置进行比较。具体 该项目的目的是（1）证明非手术CASA干预可改善症状和手 腕管综合征患者的功能； （2）比较CASA干预的临床结果 进行假干预； （3）证明多站点随机的可行性和可伸缩性 比较CASA干预和假干预的受控全尺度临床试验。我们假设（i） CASA干预的四个星期将减轻腕管综合征症状并改善手部功能 并且有益的影响将持续到干预期之外； （ii）CASA干预将导致 症状和功能比假干预更大； （iii）招聘是可行的， 保留率和合规性将是可以接受的，治疗将是安全的。该试验临床的结果 试验将使我们能够了解CASA干预，精炼样本量，设置的预期治疗效果 对患者合规性和辍学率的期望，并告知大型多站点的设计 CASA干预的随机对照临床试验。这项试验审判是我们准备的关键步骤 有效启动全尺度的多站点临床试验，最终翻译了我们的科学功绩 CASA的生物力学原理和研究结果成为腕管的新型非手术治疗 综合征。